Manager, Regulatory Affairs CMC

Role: Regulatory CMC Manager supporting Kite's autologous CAR T-cell therapy portfolio, overseeing global regulatory submissions and lifecycle management for clinical and commercial programs. Responsibilities: lead CMC regulatory strategies, author and review module content for submissions (INDs, BLAs, variations), ensure global regulatory alignment, manage risk assessments, and support interactions with health authorities. Serve as key cross-functional partner with Technical Operations, Quality, and Manufacturing teams. Qualifications: Bachelor’s degree with 6+ years or Master’s with 4+ years in regulatory affairs, drug development, or related fields; experience with biologics, cell/gene therapies, or autologous CAR T-cell products preferred. Skills: strong communication, project management, and knowledge of global regulatory requirements (FDA, EMA). Experience in clinical development, lifecycle management, and GxP environments necessary. High-value specifics: focus on cell therapies, early to late-stage development, emphasizing regulatory submissions, change management, and international compliance. Work setup: hybrid (2 remote/3 onsite) in Santa Monica, CA, with planned relocation by 2027; minimal supervision, fast-paced biotech environment.